APO-IMIQUIMOD imiquimod 50 mg/g cream sachet

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

imiquimod

Disponible depuis:

Arrow Pharma Pty Ltd

DCI (Dénomination commune internationale):

Imiquimod

Statut de autorisation:

Registered

Notice patient

APO-IMIQUIMOD CREAM
_Contains the active ingredient imiquimod_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about imiquimod. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Imiquimod. It contains the active
ingredient imiquimod.
It is used to treat:
•
Solar keratosis on the face and
scalp.
Solar keratosis is thickened, scaly
patches of skin caused by too
much sun exposure. It is also
known as actinic keratosis.
•
Superficial basal cell carcinoma
(a type of skin cancer).
•
External genital/perianal warts
(condyloma acuminate). They
appear on the surface of the penis
or vulva (external female sexual
organ) and around the anus.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Imiquimod is an immune response
modifier. It activates immune cells in
the body. The immune cells then
proceed to kill and remove the virus-
infect

Résumé des caractéristiques du produit

1
AUSTRALIAN PRODUCT INFORMATION
APO-IMIQUIMOD (IMIQUIMOD) CREAM
1
NAME OF THE MEDICINE
Imiquimod.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imiquimod 50 mg/g (5% w/w) cream.
Each 250 mg single-use sachet contains 12.5 mg imiquimod, as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Methyl hydroxybenzoate, propyl hydroxybenzoate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White, soft cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-Imiquimod 50 mg/g (5%) cream is indicated for:
•
Treatment of solar (actinic) keratosis on the face and scalp (see
section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE);
•
Primary treatment of confirmed superficial basal cell carcinoma where
surgery is
considered inappropriate;
•
Treatment of external genital and perianal warts/condyloma acuminata
in adults (see
section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Imiquimod cream is intended for topical administration.
Imiquimod cream is provided in single use sachets. A new sachet should
be opened for each
treatment, and cream from a previously opened sachet should not be
used.
Before applying imiquimod cream, the patient should wash the treatment
area with mild soap
and water, and allow the area to dry thoroughly. Imiquimod cream is to
be applied to the
affected area prior to normal sleeping hours and should be left on the
skin for approximately 8
hours (6-10 hours). The cream should be rubbed in until it is no
longer visible. Following the
treatment period the cream should be removed by washing the treated
area with mild soap
and water. During the 6-10 hours treatment period showering or bathing
should be avoided.
Hand washing before and after cream application is recommended.
Local skin reactions (erythema) at the treatment area are common.
These reactions may be
due to the pharmacological response of the body’s immune system to
imiquimod. In clinical
studies in patients with sBCC the histologic